Introduction to the CTA & NDA process in China

Introduction to the CTA & NDA process in China

Jie Zhang, Regulatory Affairs, Abbott China

Presented by: Peter van Amsterdam, Clinical Pharmacology & Bioanalytics, Abbott Netherlands

EBF/CBF `China Days', 11-12 September, Maritim Hotel, Berlin, Germany

Overall Regulatory Environment*

? Evolving ? Challenges and Opportunities ? Ever-changing and unpredictable policy & rules ? Conservative CFDA (previous SFDA) climate ? Lengthy IND/CTA process ? Local sample testing & clinical trial required ? Biologics ? stringent guidelines and longer review**

*) From: Victoria Elegant ? Critical Success Factors for Clinical Trials in Emerging Markets (2013) () **) 2014: Timelines for chemical drugs have increased and have become similar to biologics

Key Regulatory Players in China

Ministry of Health (MOH)

China Food and Drug Administration (CFDA)

Center for Drug Evaluation (CDE)

National Institute for Food and Drug Control

(NIFDC)

Province Institute for Food and Drug Control

(PIFDC)

General Registration Flow Chart

Applicant

Dossier Reception Office (CFDA)

CDE Technical Review

NIFDC QC Test

CFDA Approval (CTP/License)

Approval Timeline for Chemical drug (based on RDPAC survey)

? IDL-CTA: ? IDL-NDA: ? IMCT-CTA: ? IMCT-NDA:

36?4 m 29?4 m 13?2 m 36?4 m

CTA = Clinical Trial Application, IDL = Import Drug License, IMCT = International Multi-country Clinical Trial, NDA = New Drug Application, RDPAC = R&D-based Pharmaceutical Association Committee

Minimal study cases requirements for clinical trials in China

Item Import Chemical Drug

Biological Product

Phase PK

Phase III Phase I Phase II Phase III

Sample Size 8-12

100 pairs 20 (testing group) 100 (testing group) 300 (testing group)

? For biological products only very few companies go through Phase I to III entirely.

? The estimation of local number of study cases is based on regulation, experiences, specific indications and can be discussed.

Pre-approval requirements for Clinical Trial Applicants (I)

? Safety evaluation in pre-clinical studies should comply with GLP.

? Clinical trials (including bioequivalence studies) should be conducted in compliance with GCP.

? Drugs used for clinical trials should be manufactured in facilities in compliance with GMP.

? A drug can be used for a clinical trial only after being tested and qualified.

? Vaccines, blood products and other biological products specified by the CFDA should be tested by drug testing institutes designated by the CFDA.

Pre-approval requirements for Clinical Trial Applicants (II)

All clinical trials (including bioequivalence studies) need prior CFDA approval.

? The approved clinical trial should be conducted in a certified research institution that operates in compliance with Chinese GCP.

? For overseas applicants intending to conduct an international multicenter clinical trial in China, the drug should already be approved or in phase II or III clinical trial overseas. While approving the conduct of an IMCT, the CFDA may require the applicant to first conduct a phase I trial in China.

? Any preventive vaccine trial not having first been registered overseas is prohibited in China.

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